Inspections, Compliance, Enforcement, and Criminal Investigations
Chantel's Cakes & Pastries 4/1/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
April 1, 2011
Return Receipt Requested
Mr. Dennis L. Stanley, Owner
Chantel’s Cakes & Pastries
506 Shaw Road, Suite 308
Sterling, VA 20166
Dear Mr. Stanley:
The Food and Drug Administration (FDA) inspected your manufacturing facility located at 506 Shaw Road, Suite 308, Sterling, Virginia, from November 30, 2010 through January 6, 2011. The inspection revealed insanitary conditions and serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 – Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation. Because your bakery products have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health, your bakery products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)]. You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
Your significant violations were as follows:
1. Your firm failed to take effective measures to exclude pests from the processing areas and protect against contamination of food, as required by 21 CFR 110.35(c). Specifically observed were the following:
• Large numbers of rodent excreta pellets (REPs) observed throughout your firm were found on, and around pallets and shelving containing finished food product, raw materials used by your firm, packaging materials used by your firm, and manufacturing equipment.
• Dead rodents observed next to a cooler and a freezer containing raw materials used by your firm.
2. Your firm failed to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f). Specifically observed were the following:
• Your firm does not have a dumpster at the facility and stores garbage in the warehouse located at the rear of the facility.
• Unused equipment including 3 refrigerators, an oven, a sink, catering pans, cake stands, and baskets were observed stored in the warehouse.
3. Your firm failed to provide running water for cleaning of equipment, utensils and food-packaged materials as required by 21 CFR 110.37(a). Specifically, the hot water handle on your firm’s three compartment sink was observed to be broken off and no hot water was available to that sink.
4. Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically observed were the following:
• Your firm’s plastic strip curtain separating the warehouse from the processing room was missing at least one panel.
• The bay door located in the warehouse contained three gaps allowing easy access for pests.
Furthermore, the FDA has determined that your facility is subject to the registration requirement in section 415 of the Act, [21 U.S.C. 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection of your facility located at 506 Shaw Road, Suite 308, Sterling, Virginia, from November 30, 2010 through January 6, 2011 you were advised of this requirement. The failure to register a facility as required is a prohibited act under 301(dd) of the Act, [21 U.S.C. 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility’s owner, operator, or agent in charge, may register the facility by mail or fax (e.g. if you do not have reasonable access to the Internet) using FDA’s food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301) 575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.
This letter may not list all the violations at your facility. You are responsible for ensuring that your manufacturing facility operates in compliance with the Act and the CGMP regulation for foods (21 CFR Part 110). You also have the responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We strongly recommend you determine the cause(s) of the rodent/pest infestation, and take all necessary corrective actions. Failure to implement lasting corrective action may result in regulatory action being initiated by FDA without further notice. This action may include seizure and/or injunction against you and your company.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycut@fda.hhs.gov.